MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PROVENA MIDLINE 3F SL; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer that the lip of the micro introducer folded in on itself during procedure.No other information was provided.
Event or Problem Description
It was reported by the customer that "a couple of weeks ago i did a 3 fr and couldn't advance the introducer because a lip formed on the end and wouldn't penetrate the vein.".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of difficulty inserting an introducer was confirmed and appears manufacturing related.One 3.5 fr x 7cm microez microintroducer was returned for evaluation.The shaft was observed to be curved.Blood residue and evidence of use was noted.Microscopic inspection of the distal end of the sheath revealed inward bunching and deformation.The sheath tip taper appeared to be blunt.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h11.
Event or Problem Description
It was reported by the customer that "a couple of weeks ago i did a 3 fr and couldn't advance the introducer because a lip formed on the end and wouldn't penetrate the vein.".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: PROVENA MIDLINE 3F SL
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16765852
• Report Number: 3006260740-2023-01404
• Device Sequence Number: 14978764
• Product Code: PND
• UDI-Device Identifier: 00801741188763
• UDI-Public: (01)00801741188763
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000879
• Device Lot Number: REGW2274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 04/27/2023; 09/27/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/05/2023; 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown